This post is from the non-Reed Smith side of the blog.
We’ve been updating you regularly on the equally regular dismissal of the majority of claims in the Infuse litigation on the grounds of preemption and TwIqbal. Well, here’s a quick reminder that preemption isn’t the only arrow in device manufacturers’ quivers. All those
This post is from the non-Reed Smith side of the blog only.
Since September we’ve been bringing you news from the Infuse litigation on about a monthly basis. The overwhelming majority of that news has been positive. And, when you’ve got a good thing going, you want to keep it going. You also don’t want
This post discusses an Infuse case and therefore, is from the non-Reed Smith side of the blog only.
“Mother of mercy, is this the end of Rico?” Those are the last words uttered by the gangster in Little Caesar. That villain was played by Edward G. Robinson, who became well-known for playing tough-talking hoodlums,
This post is from the non-Reed Smith side of the blog.
Have you ever told someone, “I’ll put it in the vault” or “not that there’s anything wrong with that”? Or yelled “Serenity Now!” in a chaotic situation. How about offered someone a “you are so good looking” after a sneeze? If not,
This post is from the non-Reed Smith side of the blog.
We embrace all defense wins on this blog. From the small and routine to the precedent-setting. From discovery violations to appeals and everything in between. And we are certainly no strangers to talking about removal issues. So, of course we want to share with our readers H.R. ex rel. Reuter v. Medtronic, Inc., 2014 WL 554454 (S.D. Ohio Feb. 13, 2014), and more specifically, the court’s decision that defendant properly removed the case in light of “substantial federal issues” within the meaning of Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005). But, don’t go filing your removal papers quite yet. Anything involving Grable is hardly a one size fits all argument, and we caution everyone to look closely at all aspects of your case (especially the jurisdiction) before attempting to squeeze anything into this slender and contorted federal question category.
The Grable argument isn’t new. We’ve pondered it before because the restriction of theories via PMA preemption to “parallel” claims involving FDA violations does seem to push that type of case towards Grable. But frankly, our idea hasn’t had much success. Which also isn’t surprising. The general principle is to use the presence of an issue implicating federal law – but something less than a federal cause of action – as a basis of obtaining subject matter jurisdiction in federal court. Removal is appropriate where a state court claim “necessarily raise[s] a stated federal issue [that is] actually disputed and substantial, which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial responsibilities.” Grable, 545 U.S. at 312. That last part, about “balance,” means that by definition Grable doesn’t apply to anything involving large numbers of cases. So look elsewhere for jurisdictional panaceas.
H.R. is an InFuse case. If you haven’t been following our other InFuse posts, InFuse is a PMA, Class III medical device. In almost all of the InFuse cases, including H.R., plaintiffs’ claims are based on alleged off-label promotion of the device which they claim violates the FDCA. The combination of a PMA device and plaintiff’s extensive, and nearly exclusive, reliance on detailed FDCA-related allegations involving off-label promotion are what made H.R. a particularly strong vehicle for advancing the Grable substantial federal question argument.Continue Reading A Removal Win With a Word of Caution
This post is from the non-Reed Smith side of the blog.
It was the best of decisions (Scovil v. Medtronic, Inc., __ F. Supp.2d __, 2014 WL 502923 (D. Ariz. Feb. 7, 2014), it was the worst of decisions (Coleman v. Medtronic, Inc., No. B243609, slip op. (Cal. App. Jan. 27,
This post is from the non-Reed Smith side of the blog only.
It has been almost two months since we’ve posted about an InFuse decision and in case you’ve forgotten, the InFuse litigation has been making a lot of great off-label use law (see most recent post with links to early posts). And now
This post is from the non-Reed Smith side of the blog only.
This year has seen many decisions in the InFuse litigation and we’ve tried to highlight the key rulings. See here and here. They mostly have been very strong preemption decisions and this month’s addition to the collection is no exception – Cook
This post is from the non-Reed Smith side of the blog only.
A few weeks ago we brought you up to speed on the goings on around the country in the Infuse litigation. We’ve decided not to let the cases pile up again and so, today’s post is on the latest Infuse decision – Eidson v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 144179 (N.D. Cal. Oct. 3, 2013). Like most of the decisions this summer, this one is strong on preemption and ultimately, it dismisses most of plaintiffs’ claims.
Eidson actually involves two related cases – claims by Mr. Eidson and claims by Mr. and Mrs. Bell. The allegations are more or less the same. The Infuse bone graft system is a Class III medical device approved by the FDA through the Premarket Approval (“PMA”) process. The system was approved as a medical device consisting of three parts (a spinal fusion cage, a bone graft substitute, and a spongy carrier) for use in anterior (through the abdomen) lumbar surgery. Both plaintiffs allege that the device was used off-label in their surgeries because it was implanted posteriorly (through the back) and without the spinal fusion cage. Eidson, 2013 U.S. Dist. LEXIS 144179, at *6-7. At the outset, both plaintiffs also abandoned their strict liability design defect claims as barred by California law. Id. at *57-58.